01. Adult Immunization

Faculty Editor: Luis Alberto Rubio, MD

BOTTOM LINE

✔ CDC adult vaccination schedule, updates, and tools available at: https://www.cdc.gov/vaccines/schedules/index.html

Commonly indicated adult immunizations are discussed below and generally follow the Advisory Committee on Immunization Practices (ACIP) 2018 recommendations and the IDSA 2013 clinical practice guidelines for vaccination of the immunocompromised host (Rubin et al).  Vaccines for international travelers, bioterrorism, and post-exposure prophylaxis are not discussed. Readers are directed to CDC guidelines for further reference. Finally, the recommendations below contain some information for vaccination of specialized populations including pregnant persons and immunocompromised patients. However, full discussion is beyond the scope of this chapter, and readers are referred to additional CDC and Infectious Diseases Society of America (IDSA) guidelines for full discussion. Involvement of patients’ obstetricians and subspecialists should also be considered.

General Contraindications

  • Severe allergic reaction or anaphylaxis to the same vaccine previously
  • Severe allergic reaction or anaphylaxis to vaccine component is a contraindication to subsequent vaccination with the same vaccine or any vaccines with shared components (e.g. tetanus toxoid or other adjuvants)
  • See specific immunization sections below for vaccine-specific precautions and contraindications

General precautions

  • Moderate to severe illness with or without fever is a precaution to the administration of any adult vaccine, and deferment until after recovery is generally recommended.
  • Mild illness with or without fever should not affect the decision to vaccinate.
  • See specific immunization sections below for vaccine-specific precautions and contraindications

Pregnancy

  • Contraindication to the administration of live vaccines including MMR (measles, mumps, rubella), VAR (varicella), ZVL (Zostavax®), and LAIV (live-attenuated influenza vaccines)
  • Precaution for the administration of the HPV vaccine
  • Recombinant and some inactivated vaccines may be safe
  • Package inserts for other vaccines may list pregnancy as a precaution, but ACIP does not
  • There are pregnancy registries for many of the vaccines discussed below
  • Consider consultation with your patient’s obstetrician

Immunocompromised Hosts

  • Contraindication to the administration of live vaccines
  • Recombinant and some inactivated vaccines may be safe
  • May require different doses or schedules to generate protective immunity
  • See also ACIP, CDC, and Infectious Diseases Society of America (IDSA) guidelines
  • Consider consultation with your patients’ subspecialist(s)

Adverse Events

  • Usually mild and self-limited
  • Include local pain or swelling, fatigue, syncope, fever
  • Report to Vaccine Adverse Events Reporting System (VAERS) (www.vaers.org)

Haemophilus influenzae serotype b (Hib)

  • Three monovalent conjugated vaccines against a Hib capsular polysaccharide (PRP) available:
    • ActHIB® (conjugated to tetanus toxoid)
    • PedvaxHIB® (conjugated to outer membrane protein complex of Neisseria meningitidis)
    • Hiberix® (conjugated to tetanus toxoid)
  • Part of routine childhood vaccination in the U.S.
  • No vaccines available for nontype b and nontypeable H. influenzae

Indications: 

  • Adults with anatomic or functional asplenia if previously unvaccinated*
  • Prior to elective splenectomy if previously unvaccinated*
  • Hematopoietic stem cell transplant (HSCT) regardless of vaccination history†
  • HIV infection is NOT an indication in adults

Schedule:

  • *One dose
  • †Three total doses separated by at least 4 weeks, start 6-12 months post-transplant
  • Preferred but not necessary to complete the series with the same brand product.

Vaccine-specific contraindications:

  • Severe allergy or anaphylaxis to natural rubber latex

Vaccine-specific precautions (Hiberix®, ActHIB® only):

  • Gullain-Barré syndrome within 6 weeks of a prior tetanus toxoid-containing vaccine according to package insert (not discussed by ACIP)

Hepatitis A virus (HAV)

  • Two inactivated HAV vaccines available:
    • HAVRIX®
    • VAQTA®
  • WINRIX® combines inactivate HAV and recombinant hepatitis B surface antigen.
  • Part of routine childhood immunization in the U.S.
  • Vaccination is 94% effective

Indications:

  • Chronic liver disease
  • Persons living with HIV aged ≥1 year old
  • Men who have sex with men
  • Pregnant persons at risk for HAV infection or severe outcome from HAV
  • All children and adolescents aged 2-18 years who have not previously received HepA vaccine
  • Homelessness
  • Injection and non-injection illicit drug users
  • Occupational exposure to HAV or HAV-infected animals
  • Travel to areas with intermediate to high rates of endemicity
  • According to Rubin et al., after hematopoietic stem cell transplant (HSCT)
  • According to Rubin et al., solid organ transplant or transplant candidacy
  • Close family contacts of adopted children from areas with intermediate to high rates of endemicity
  • Post-exposure prophylaxis (PEP) for adults <= 40 years old.
  • PEP for adults > 40 years old if HAV immunoglobulin not available

Schedule:

  • HAVRIX®: Two total doses at 0 and 6-12 months
  • VAQTA®: Two total doses at 0 and 6-18 months
  • TWINRIX®: Three total doses at 0, 1, and 6 months.
  • HAVRIX® and VAQTA® are likely interchangeable.

Test for immunity:

  • Pre-vaccination testing of total anti-HAV
    • Consider for populations expected to have high prevalence of immunity from prior infection, including those born in areas with intermediate to high endemicity, injection drug users, and potentially older adults.
  • Post-vaccination testing of total anti-HAV
    • NOT recommended
    • Vaccine is highly effective
    • Immune individuals may not have detectable antibody

Vaccine-specific precautions:

  • Safety in pregnant persons is limited (generally not given unless patient is high risk for acquiring HAV)

Hepatitis B virus (HBV)

  • Two vaccines with recombinant hepatitis B surface antigen (HBsAg) and alum:
    • Energix B®
    • Recombivax HB®
  • One vaccine with recombinant HBsAg and novel synthetic CpG adjuvant:
    • Heplisav-B®
    • Approved for adults in 2017
    • Limited data available compared to Energix B® and Recombivax B®
  • TWINRIX® combines inactivated HAV and recombinant HBsAg
  • Part of routine childhood immunization in the U.S.
  • Vaccination yields 90% rate of seroconversion (proxy for immunity)

Indications for primary vaccination of adults not previously vaccinated (appropriate primary and boosting schedule indicated by superscript):

  • ACIP now recommends universal HepB vaccination in all adults aged 19-59
  • Adults aged ≥60 years without risk factors for HepB may receive HepB vaccines
  • Adults aged ≥60 years with risk factors for HepB listed below:
  • Multiple sexual partners within the prior 6 months
  • Sexual activity with an HBV-infected partner*†
  • Men who have sex with men (MSM) *
  • Treatment for a sexually transmitted infection
  • Illicit injection drug use*
  • Household contacts of HBV-infected individuals*
  • Consider for diabetes mellitus
  • Pre-dialysis and dialysis patients*†
  • Incarceration
  • HIV infection*†
  • Hepatitis C virus infection
  • Chronic liver disease
    • Fatty liver disease
    • Alcoholic liver disease
    • Autoimmune hepatitis
    • Cirrhosis
    • AST/ALT elevations at least twice the upper limit of normal
  • Health-care personnel and public-safety workers who may be exposed to blood or body fluids of HBV-infected individuals†
  • Clients and staff of institutions for persons with developmental disabilities
  • Patients who receive healthcare at facilities with a high prevalence of HBV infection
  • Travel to countries with intermediate to high prevalence of endemic infection
  • According to Rubin et al., after hematopoietic stem cell transplant or HSCT (no sooner than 6 months) *†
  • According to Rubin et al., solid organ transplant (and candidacy) if not vaccinated previously*†
  • Post-exposure prophylaxis

Indications for revaccination (full series) or boosting (single dose):

  • Indicated for the following groups with post-vaccination level of antibody to hepatitis B surface antigen (anti-HBs) of  <10 mIU/mL
  • Healthcare personnel and public safety workers†
  • Pre-dialysis and dialysis patients *†
  • Sexual partners of HBV-infected individuals*†
  • HIV-infected patients*†
  • After hematopoietic stem cell transplant (consider high-dose regimen for revaccination of a non-responder according to Rubin et al.) *†
  • Solid organ transplant candidacy or after solid organ transplant (consider high-dose regimen for revaccination of a non-responder according to Rubin et al.) *†
  • Treatment with chemotherapy (to start no earlier than 3-months post-chemotherapy and 6-months post-B-cell directed biologics) *†

Schedule/Dosing:

  • Most adults (NOT dialysis, pre-dialysis, or immunocompromised)
    • Energix B®
      • Age <=19 years: 10 mcg at 0, 1, and 6 months
      • Age >=20 years: 20 mcg at 0, 1, and 6 months
    • Recombivax HB®
      • Age <=19 years: 5 mcg at 0, 1, and 6 months
      • Age >=20 years: 10 mcg at 0, 1, and 6 months
    • TWINRIX® (age >=18 years):
      • Standard: Three total doses at 0, 1, and 6 months
      • Accelerated: Four total doses at 0 days, 7 days, 21-30 days, and 12 months
    • Heplisav-B® (age >=18 years): Two total doses (20 mcg per dose) at least 4 weeks apart
  • High dose regimens for pre-dialysis and dialysis patients (age >=20 years)
    • Energix B®: 40 mcg (2 x 1 ml doses) at 0, 1, 2, and 6 months
    • Recombivax HB®: 40 mcg at 0, 1, and 6 months.
    • Heplisav-B®: Two total doses (20 mcg per dose) at least 4 weeks apart
  • Immunocompromised adults: consider high dose Recombivax HB® or high dose Energix B® schedules as above
  • If schedule interrupted, resume as soon as possible, but no need to restart.
  • Completion of the series with same brand is preferred but not necessary. However, if the first dose was Heplisav-B® and the series is being completed with Recombivax HB® or Energix B®, three total doses will be needed (rather than two).

Test for immunity:

  • Anti-HBs level >= 10 mIU/mL correlates with protection against HBV infection only in persons who have received a complete 3-dose vaccination series.
  • *Pre-vaccination testing:
    • Do not delay vaccination for serologic testing
    • Consider checking hepatitis B surface antigen, anti-HBs level, and antibody level to hepatitis B core antigen (anti-HBc level) for some groups
      • Marked with the * symbol above
      • Immigrants from areas with intermediate to high prevalence of endemic HBV infection
      • U.S.-born individuals with parents from high prevalence areas who were not vaccinated as children
      • Blood and tissue donors
      • Anyone with AST/ALT elevations of unknown etiology.
  • †Post-vaccination testing:
    • Check anti-HBs level 1-2 months after the final dose for some groups
      • Marked with the † symbol above
      • Immunocompromised patients
    • Annual anti-HBs level testing indicated for some groups
      • Hemodialysis patients
      • Considered for immunocompromised persons
      • Consider for persons at continued risk of HBV infection
    • Consider single booster dose or complete repeat series if the anti-HBs level < 10 mIU/mL.

Vaccine-specific contraindications:

  • Severe allergy or hypersensitivity to yeast (Energix B®, Recombivax HB®, or Heplisav-B®)

Human Papilloma Virus (HPV)

  • One recombinant antigen vaccine currently in distribution: Gardasil 9®
    • Effective against types 6, 11, 16, 18, 31, 33, 45, 52, and 58
  • Cross-protection against non-vaccine types has been observed
  • 95-98% efficacy for prevention of cervical intraepithelial neoplasia 2 (CIN2) in women without evidence of past vaccine-type HPV infection
  • 51%-60% efficacy for prevention of CIN2 in women without regard to HPV status at the time of vaccination
  • 79%-99% efficacy for prevention of genital warts in women
  • 67-89% efficacy for prevent of genital warts in men
  • 57-79% efficacy in prevent of anal intraepithelial neoplasm in MSM
  • No role for treatment of current infection or prevention of disease progression

Indications:

  • All adolescents age 11-12 (consider as early as age 9) regardless of gender or risk factors
  • Catch-up vaccination for all adults through age 26 if not previously vaccinated
  • Consider for adults ages 27-45 (shared decision-making recommended)
  • History of genital warts, abnormal PAP smear, or positive HPV DNA should not preclude vaccination.

Schedule:

  • First dose given ages 9-14:
    • Non-immunocompromised: Two total doses separated by 6-12 months
    • Immunocompromised: Three total doses at 0, 1-2, and 6 months
  • First dose given age >=15
    • Healthy or immunocompromised: Three total doses at 0, 1-2, and 6 months.
  • An interrupted series may be resumed and does not need to be restarted.
  • Completion of series with the same brand is preferred but not required.

Vaccine-specific contraindications:

  • Immediate hypersensitivity or anaphylaxis to yeast

Vaccine-specific precautions:

  • Pregnancy. Defer until after delivery even if a series previously started. No need to test for pregnancy prior to vaccination.

Influenza virus

  • Multiple multivalent inactivated influenza virus vaccines (IIV), recombinant influenza virus vaccines (RIV), and a live-attenuated influenza virus vaccine (LAIV4) made available annually.
  • Composition and valency vary each year based on surveillance data and predictions for circulating strains
  • Effectiveness varies each year

Indications:

  • All persons at least 6 months old with no contraindication
  • In the event of shortage, prioritize at-risk populations and their close contacts:
    • Pregnant women
    • Children 6-59 months old
    • Adults >=50 years old
    • People with chronic medical disorders (including diabetes)
    • Immunocompromised persons
    • Nursing home residents
    • American Indians
    • Alaskan Natives
    • BMI >=40
    • Healthcare personnel
    • Care-takers of at-risk populations

Schedule/Dosing:

  • One dose annually of any recommended vaccine early in the flu season
  • Check ACIP annual guidelines for available/recommended formulations: https://www.cdc.gov/flu/protect/vaccine/vaccines.htm
  • Consider high-dose inactivated trivalent (HD-II3; FluZone High Dose®) for adults age >=65 based on data for superior efficacy in this age group
    • Not a current ACIP recommendation
    • Do not delay vaccination to obtain a particular formulation.

Vaccine-specific contraindications:

  • IIV:
    • Severe allergy to any prior influenza vaccine
    • Egg allergy*
  • RIV:
    • Severe allergy to any vaccine component
  • LAIV:
    • Severe allergy to any prior influenza vaccine
    • Egg allergy*
    • Pregnancy
    • Immunocompromise or immunosuppression (Rubin et al.)
      • Current chemotherapy (safe at least 3 months after chemotherapy or at least 6 months after administration of B-cell depleting antibodies)
      • Pre- and post-hematopoietic stem cell transplant (HSCT)
      • Pre- and post-solid organ transplant
      • Current or planned iatrogenic immunosuppression
      • Asplenia
      • Sickle cell disease
      • HIV regardless of CD4 count.
    • Close contacts of severely immunosuppressed individuals
    • Use of anti-influenza medications within 48 hours
    • Age <=2 years or age > 49 years

Vaccine-specific Precautions:

  • IIV:
    • History of Guillain-Barré syndrome (GBS) within 6 weeks of prior flu vaccination
    • Egg allergy*
  • RIV:
    • History of GBS within 6 weeks of prior flu vaccination
  • LAIV:
    • History of GBS within 6 weeks of prior flu vaccination
    • Egg allergy*
    • Asthma
    • Most chronic medical comorbidities

*Egg allergy:

  • Listed as a contraindication on package inserts of IIV and LAIV vaccines.
  • ACIP recommendations differ:
    • Hives-only egg allergy:
      • Administer any age-appropriate vaccine
    • Severe egg allergy (anaphylaxis or respiratory distress)
      • Administer any age-appropriate vaccine in a supervised healthcare setting (including outpatient)
  • RIVs are considered egg-free

Measles/Mumps/Rubella

  • One live-attenuated vaccine (MMR) available which includes all three viruses
  • 97% effective in preventing measles and rubella
  • 88% effective in preventing mumps

Indications (appropriate schedule indicated with superscript):

  • All adults without evidence of immunity to measles, mumps, or rubella (see “evidence of immunity” below)*

Special populations at particular risk or consequence of the noted virus (appropriate schedule indicated with superscript):

  • Measles (unless evidence of immunity to measles)
    • College and university students**
    • International travelers**
    • Healthcare personnel**
    • Household contacts of immunocompromised persons (measles)**
    • HIV-positive patients with CD4 count > 200 and CD4% >=15% for at least 6 months**
    • Prior vaccination with killed/inactivated measles vaccine (available 1963-1967 in the U.S.) **
    • At-risk adults during a measles outbreak (identified by health dept)*
    • Post-exposure prophylaxis (see guidelines for schedule)
    • >= 24 months after hematopoietic stem cell transplant (HSCT) if measles seronegative, no GVHD, and not on immunosuppression per Rubin et al. **
  • Mumps (unless evidence of immunity to mumps)
    • At-risk adults during a mumps outbreak (identified by health dept)*
  • Rubella (unless evidence of immunity to rubella)
    • Women of child-bearing age or planning pregnancy†
    • Pregnancy§

Evidence of immunity:

  • Birth prior to 1957 (not sufficient for women of childbearing age, pregnant women)
  • Laboratory evidence of immunity to the appropriate virus (e.g. serum IgG titer)
  • Laboratory evidence of past infection (clinical diagnosis not sufficient)
  • Documentation of appropriate prior MMR administration as below
    • Measles: Two doses of a live-attenuated measles-containing vaccine at age >= 12 months separated by at least 28 days. Do not consider doses administered within 6 months of immunoglobulin or high-titer measles immune globulin, vaccine of unknown type, or killed or inactivated vaccine which were previously available. 
    • Mumps: Two doses of a live-attenuated mumps-containing vaccine at age >= 12 months separated by at least 28 days. Do not consider doses of vaccine of unknown type or killed mumps vaccine which was previously available.
    • Rubella: One dose of live-attenuated rubella-containing vaccine at age >= 12 months
    • For individuals with perinatal HIV infection, only consider doses administered when on effective ART, CD4 count >=200, and CD4% >=15% for >= 6 months at the time of administration

Schedule:

  • *One dose (except as noted for special populations below)
    • No more than two total doses of MMR or MMRV for measles outbreak
    • Second or third dose may be indicated for mumps outbreak
  • **Two doses separated by at least 28 days (or one additional dose if there is documentation of one prior MMR or MMRV dose)
  • †One dose at least 4 weeks prior to pregnancy
  • §One dose after delivery or termination and prior to discharge

Test for immunity:

  • Antibody titers to measles, mumps, or rubella
  • Not routinely recommended post-vaccination
  • Can be used to establish evidence of immunity if no other evidence of immunity
  • Documentation of appropriate vaccine administration (as described above) is considered evidence of immunity even if titer is negative or equivocal (except for pregnancy or planned pregnancy)

Vaccine-specific contraindications:

  • Current or planned (within 4 weeks) pregnancy
  • Severe allergy to neomycin or gelatin
  • Immunosuppression
    • Primary or acquired immunodeficiency,
    • HIV with CD4 count <200 or CD4% < 15%
    • Hypogammaglobulinemia
    • Blood dyscrasias, malignancies affecting the bone marrow or lymphatic system
    • Systemic immunosuppression (prednisone 20 mg/d for at least 2 weeks or equivalent per ACIP; per Rubin et al., however, lower doses of prednisone and other immunosuppressives are also a contraindication),
    • < 4 weeks prior to or during chemotherapy (Rubin et al.) but consider administering starting 3 months after chemotherapy if otherwise indicated
    • <4 weeks prior to HSCT
    • <24 months after HSCT
    • Family history of severe immunodeficiency in a 1st degree relative (unless immunocompetency has been established previously),
    • Solid organ transplant (Rubin et al.)

Vaccine-specific precautions:

  • History of thrombocytopenia or thrombocytopenic purpura (may precipitate thrombocytopenia)
  • Antibody-containing blood product administration within 11 months (may limit effectiveness of vaccine). In general, delay until 11 months has elapsed with the exception of pregnant women lacking rubella immunity who should still be immunized immediately after delivery.
  • Need for tuberculin testing. PPD can be placed same day or must be postponed for at least 4 weeks

Neisseria meningitidis (meningococcus)

  • Neisseria meningitidis serogroups B, C, and Y cause most of the morbidity and mortality
  • Three quadrivalent protein-polysaccharide vaccines available for serogroups A, C, W-135, and Y (also called MenACWY)
    • Menactra® contains diphtheria toxoid
    • Menveo® contains diphtheria CRM197, an inactive mutant diphtheria toxin
    • MenQuadifi® contains tetanus toxoid carrier (approved in 2020)
  • Two approved vaccines for serogroup B (also called MenB)
    • Trumenba® (or MenB-FHbp) contains recombinant lipidated protein antigens
    • Bexsero®  (or MenB-4C) contains recombinant proteins and outer membrane vesicles
  • Both MenACWY and MenB are now part of routine adolescent immunization

Indications if not previously vaccinated for the respective serogroup (appropriate primary and boosting schedule indicated with superscript):

  • Anatomic or functional asplenia (e.g. sickle cell disease, hemoglobinopathies)*§b
  • Complement component deficiencies (e.g. deficiency of C3, C5-9, properdin, Factor D, or Factor H)*§b
  • HIV infection*
  • Use of eculizumab or ravulizumab*§b
  • Laboratory personnel with exposure to Neisseria meningitidis isolates†§b
  • Military recruits†
  • Travel to areas with hyperendemic or epidemic meningococcal disease†
  • Persons at increased risk during an outbreak in community or organizational settings and among men who have sex with men†§b
  • First-year college students <= 21 years living in residence halls (if no dose on or after 16th birthday)†
  • Consider for young adults age 16-23 NOT among the risk groups listed above (at the discretion of the clinician)‡
  • Local recommendations
    • Consult your local health department
    • Outbreaks of serogroup C among men who have sex with men (MSM) has led to local recommendations for MenACWY vaccination of at-risk or all MSM (e.g. San Francisco, Los Angeles County, Chicago, New York City, Minnesota)

Schedule/Dosing:

  • MenACWY:
    • *Two total doses separated by 8-12 weeks; boost with one dose every 5 years while risk factor remains
    • †One dose
    • Completion of the series with same brand is preferred but not necessary
  • MenB:
    • §Two total doses of Bexsero® at least 1 month apart OR three total doses of Trumenba® at 0, 1-2, and 6 months
    • ‡Two total doses of Bexsero® at least 1 month apart OR two total doses of Trumenba® at least 6 months apart
    • NOT interchangeable

Indications for revaccination/ boosting (MenACWY):

  • Groups marked with * above with persistent risk for serogroup A, C, W-135, or Y
  • Give one dose every 5 years while risk factor remains

Indications for boosting (MenB):

  • Groups marked with b above with persistent risk for serogroup B
  • Single dose 1 year after completion of vaccination series
  • Every 2-3 years thereafter while risk factor remains

Vaccine-specific precautions:

  • Latex hypersensitivity (Bexerso® only per data safety sheet)
  • History of GBS (Menactra® only per data safety sheet)
  • Pregnancy
    • No data in pregnant or lactating women
    • ACIP recommendations
      • If increased risk, vaccinate with MenACWY or MenB
      • If no increased risk, defer routine MenB vaccination until after pregnancy
  • Age
    • Menactra®, Menveo®, and MenQuadfi®
      • Licensed for ages 2-55 years
      • ACIP includes ages > 55 years
    • Trumenba® and Boxero®
      • Licensed for ages 10-25 years
      • ACIP includes ages > 25 years for at risk adults

Streptococcus pneumonia (pneumococcus)

  • Four component vaccines available for adults
    • Pneumovax 23® or PPSV23 is a 23-valent polysaccharide vaccine
    • Prevnar 13® or PCV13 is a 13-valent conjugate vaccine which contains diphtheria CRM197 (mutant, inactive diphtheria toxin)
    • Vaxneuvance® or PCV15 is a 15-valent conjugate vaccine contains two new serotypes in addition to PCV13 serotypes (approved 2021)
    • Prevnar 20® or PCV20 is a 20-valent conjugate vaccine contains seven new serotypes in addition to PCV13 (approved 2021)
  • PPSV23 ~ 50-80% effective in preventing invasive pneumococcal disease
  • PCV13 with ~45% efficacy in preventing vaccine-type pneumococcal pneumonia; 75% efficacy in preventing vaccine-type invasive pneumococcal disease
  • In adults aged ≥ 50 years, PCV15 recipients met noninferiority criteria to PCV13 recipients for shared serotypes and had statistically significant greater responses to shared serotype 3 and PCV15 unique serotypes   
  • PCV20 recipients elicited similar responses to all shared 13 serotypes in PCV13 recipients
  • PCV20 recipients also had higher percentage of seroresponders to six of seven shared non-PCV13 serotypes compared to PPSV23 recipients

Indications (appropriate primary and boosting schedule indicated by superscript):

  • All adults age ≥ 65 who do not fall under a risk group below*
  • Adults age 19-64 with increased risk for pneumococcal disease
    • Immuodeficiency or immunocompromise†
      • Primary cellular immunodeficiency
      • Complement deficiency, especially C1-4 deficiency
      • Phagocyte deficiency (excluding chronic granulomatous disease)
      • Hematologic or solid malignancies (prior to, during, or after chemotherapy)
      • Pre- or post-hematopoietic stem cell transplant (HSCT) if not already administered and no graft versus host disease
      • Pre- or post-solid organ transplant
      • Planned or current iatrogenic immunosuppression (use of any dose of prednisone, azathioprine, 6-mercaptopurine, methotrexate, biologic agents)
      • HIV infection
      • Anatomic or functional asplenia (including sickle cell disease, hemoglobinopathies)
      • Chronic kidney disease
      • Nephrotic syndrome
    • Cerebrospinal fluid leak‡
    • Cochlear implant‡
    • Chronic heart disease (excluding hypertension)
    • Chronic lung disease (including COPD, emphysema, asthma)
    • Chronic liver disease
    • Alcohol use disorder
    • Diabetes mellitus
    • Cigarette smoking

Schedule/dosing:

  • For adults ≥ 65 or 19-64 with increased risk of invasive pneumococcal disease without history of pneumococcal vaccination
    • One dose of PCV (either PCV20 or PCV15)
    • If PCV15 used, then it should be followed by a dose of PPSV23 seperated ≥ 1 year
    • †‡Populations benefit from shorter interval for PPSV23 dose such as ≥ 8 weeks
  • Adults with previous PPSV23 only
    • One dose of PCV (either PCV20 or PCV15) ≥ 1 year after PPSV23 dose
  • Adults with previous PCV13
    • Benefits of providing additional PCV15 or PCV20 has not been evaluated
    • Should receive PPSV23 series as recommended by prior guidelines (see below):
      • Age ≥ 65 without immunocompromising condition, CSF leak, or cochlear implant
        • One dose of PPSV23 seperated by ≥ 1 year
      • Age 19 year or older with CSF leak or cochlear implant‡
        • One dose of PPSV23 at least 8 weeks apart
        • Additional PPSV23 dose at ≥ 65 years separated by 5 years
      • Age 19 years or older with immunocompromising condition†
        • Recommend 2 doses of PPSV23 before age 65 and 1 dose at age 65 years or older
        • One dose of PPSV23 at least 8 weeks apart from PCV13 and 2nd PPSV23 dose separated by at least 5 years before age 65
        • Additional dose given at ≥ 65 years separated by 5 years from prior PPSV3 dose
  • General principles
    • PCV will be given once per lifetime (age 65 in immunocompetent individuals or ages 19-64 in at-risk individuals)
    • For any person with a current indication for PCV, administer according to schedule above even if PPSV23 has been previously given
    • For PCV followed by PPSV23, separate by at least 1 year in immunocompetent patients and by at least 8 weeks in at-risk groups
    • For PPSV23 followed by PCV, separate by at least one year, all groups
    • For those who previously received PCV13, no additional PCV needed, but would administer PPSV23 as scheduled
    • PPSV23 doses should be separated by at least five years in all situations
    • PneumoRecs VaxAdvisor can help determine which pneumococcal vaccine a patient needs and when: https://www2a.cdc.gov/vaccines/m/pneumo/pneumo.html

Test of immunity:

  • Not routinely recommended

Vaccine-specific contraindications:

  • Severe allergy or anaphylaxis to diphtheria toxin or vaccines containing diphtheria toxoid (PCV13 only)

Vaccine-specific precautions:

  • Pregnancy/lactation. Limited data for PCV13, no data for PPSV23.

Tetanus, diptheria, pertussis

  • Td vaccines combine tetanus and diphtheria toxoids
    • Tenivac®
    • Generic Td vaccines
  • Tdap vaccines contain tetanus toxoid, diphtheria toxoid, and pertussis antigens
    • Boostrix®
    • Adacel®
  • Part of routine childhood immunization in the U.S.
  • Immunity to pertussis wanes in 5-10 years
  • Td and Tdap generate protective antibody levels in >90% of individuals
  • Efficacy of Tdap against pertussis is ~92%

Indications (appropriate schedule indicated by superscript):

  • All adults who received childhood vaccination*
  • Any adult who was not adequately immunized in childhood†
  • Pregnant women regardless of vaccination history§
  • Post-exposure prophylaxis (PEP) for wounds‡

Schedule:

  • *Tdap at 0 months, then Td at 4 weeks and 6-12 months
  • †One dose of Tdap regardless of time since last Td or DTaP
  • §One dose of Tdap during each pregnancy (ideally early in weeks 27-36)
  • ‡Wound PEP
    • If < 3 lifetime doses of tetanus and diphtheria toxoid-containing vaccine give Td (or Tdap if not previously given) immediately regardless of wound type and complete a 3 dose-series as above*. Tetanus immunoglobulin may be indicated depending on wound type.
    • Clean, minor wounds: One dose of Td (or Tdap if not previously given) if >10 years since last tetanus-containing vaccine.
    • Other wounds: One dose of Td (or Tdap if not previously administered) if >5 years since last tetanus-containing vaccine.

Indications for revaccination/boosting:

  • One dose of Td or Tdap every 10 years.
  • Substitute Tdap one time if it has not been previously given

Test for immunity:

  • No test of immunity for pertussis
  • Serum antibody titers to tetanus and/or diphtheria toxoids are available
  • Antibody level > 0.1 mIU/mL considered protective
  • Consider checking if childhood vaccination is probable but no record available

Vaccine-specific contraindications:

  • Severe reaction or anaphylaxis to any component of Td. Note, these patients should be referred for allergy testing.
  • History of unexplained encephalopathy or neurologic condition within 7 days of prior tetanus or diphtheria toxoid or pertussis antigen-containing vaccine

Vaccine-specific precautions:

  • Acute, unstable, or progressive neurologic conditions (Tdap only). Defer until stabilization.
  • Guillain-Barré syndrome within 6 weeks of tetanus toxoid-containing vaccine (Td or Tdap)
  • Arthus reaction after prior tetanus or diphtheria toxoid-containing vaccine (Td or Tdap). Defer for 10 years between doses regardless of indication.

Varicella zoster virus primary infection (chickenpox)

  • One live-attenuated vaccine available (VARIVAX® or VAR)
  • Part of routine childhood immunization in the U.S.
  • 80% efficacy in preventing varicella among adults

Indications (appropriate schedule indicated by superscript):

  • All adults without evidence of immunity (see “Evidence of immunity” below)*
  • Pregnant women without evidence of immunity†
  • Post-exposure prophylaxis if no evidence of immunity
  • Consider for HIV-infected persons with CD4 count >=200 (ACIP). Administer only if otherwise indicated (Rubin et al.)†
  • >=2 years after hematopoietic stem cell transplant (HSCT) if varicella seronegative, no evidence of graft versus host disease (GVHD), no immunosuppression according to Rubin et al.

Evidence of immunity:

  • Birth before 1980 in the U.S. (NOT sufficient evidence for women of child-bearing age, pregnant women, healthcare personnel, or immunocompromised persons)
  • Dated documentation of prior administration of two doses of varicella-containing vaccine at least 4 weeks apart
  • History of clinical diagnosis of varicella by a healthcare provider (not patient)
  • History of clinical diagnosis of herpes zoster by a healthcare provider (not patient)
  • Laboratory evidence of immunity
  • Laboratory evidence of disease

Schedule:

  • *Two total doses separated by 4-8 weeks. Only one dose necessary if one prior varicella-containing vaccine has been administered.
  • †Immediately after delivery or pregnancy termination and before discharge from healthcare facility, give first of two doses which should be separated by 4-8 weeks. Only one dose necessary if one prior varicella-containing vaccine has been administered.
  • §Two total doses separated by 3 months
  • An interrupted schedule can be resumed without restarting

Test for immunity:

  • ELISA (more specific) and latex agglutination (more sensitive) assays available
  • Use prior to vaccination for adults without evidence of immunity
  • Not recommended post-vaccination

Vaccine-specific contraindications:

  • Severe allergy or anaphylaxis to gelatin or neomycin
  • Pregnancy or planned pregnancy within 4 weeks
  • Immunocompromise
    • Leukemias, lymphomas, blood dyscrasias, any malignancy affecting bone marrow or lymphatic system
    • HIV infection with CD4 count < 200
    • History of hereditary immunodeficiency in a first-degree relative (unless immunocompetency has been verified)
    • Chemotherapy (including within 4 weeks prior to start) (Rubin et al.)
      • Can consider > 3 months after completion
    • HSCT (including within 4 weeks prior to or 24 months after transplant) (Rubin et al.)
    • Solid organ transplant (including within 4 weeks of surgery) (Rubin et al.)
    • Chronic high-dose immunosuppression (including within <4 weeks of start) (Rubin et al.)
      • >= 20 mg/day of prednisone for >= 2 weeks according to ACIP
      • Methotrexate > 0.4 mg/kg/week (Rubin et al.)
      • Azathioprine > 3 mg/kg/day (Rubin et al.)
      • 6-mercaptopurine > 1.5 mg/kg/day (Rubin et al.)
      • Biologic immunosuppressive agents (Rubin et al.)

Vaccine-specific precautions:

  • Administration of immunoglobulin, plasma, or antibody-containing blood products within 3-11 months.
    • Defer for 3-11 months depending on risk-benefit profile.

Varicella zoster virus reactivation (herpes zoster or shingles)

  • One in three lifetime risk of herpes zoster in unvaccinated persons
  • 10-18% chance of post-herpetic neuralgia (PHN) in unvaccinated persons
  • Two vaccines available
    • Shingrix® (or RZV for recombinant zoster virus) (preferred)
      • Recombinant glycoprotein E with a novel adjuvant
      • 91% efficacy for prevention of zoster
      • Not studied in populations not previously infected or vaccinated for varicella
    • Zostavax® (or ZVL for zoster live virus)
      • Live-attenuated vaccine
      • 38-70% efficacy for prevention of zoster

Indications:

  • All adults age >=50 regardless of vaccination or infection history
    • Age 50-59:
      • ACIP recommends RZV
      • Both vaccines licensed
    • Age >=60:
      • RZV preferred but either acceptable
  • All adtuls age ≥ 19 years with immuncompromising condition
    • ACIP recommends RZV
    • ZVL should not be administered to immunosuppressed adults

Schedule:

  • RZV: Two total doses separated by 2-6 months
  • ZVL: One dose
  • If administering RZV after prior ZVL, separate by >=8 weeks
  • An interrupted schedule can be resumed and does not need to be restarted
  • RZV and ZVL are not interchangeable
  • When possible, administer RZV before patients become immunosuppressed or when immune response likely to be most robust

Vaccine-specific contraindications:

  • ZVL contraindicated in pregnancy or planned pregnancy
  • Severe allergy or anaphylaxis to neomycin or gelatin (ZVL only)
  • Severe immunocompromise (contraindication for ZVL)
    • Leukemia, lymphoma, other malignancies affecting bone marrow or lymphatic system.
    • HIV infection with CD4 count < 200, CD4% < 15%, or AIDS
    • High dose chronic systemic immunosuppression
      • >= 20 mg/day prednisone for >=2 weeks
      • Methotrexate > 0.4 mg/kg/week
      • Azathioprine > 3 mg/kg/day
      • 6-mercaptopurine > 1.5 mg/kg/day
      • Biologic immunosuppressive agents
    • Clinical or laboratory evidence of cellular immunodeficiency
    • Hematopoietic stem cell transplant (HSCT)
      • ACIP recommendations
        • Contraindicated <24 months post-transplant
        • Consider on a case-by-case basis >=24 months post-transplant.
      • Rubin et al. recommendations
        • Pre-transplant
          • Contraindicated <4 weeks pre-transplant
          • Can consider if >4 weeks pre-transplant, varicella-immune, and not on immunosuppression
        • Post-transplant: Contraindicated
    • Chemotherapy (Rubin et al.)
      • Contraindicated <4 weeks prior to or during chemotherapy
      • Can consider >=3 months after chemotherapy
  • Mild immunosuppression is not a contraindication
  • Humoral immunodeficiency (e.g. hypogammaglobulinemia) is not a contraindication

Vaccine-specific Precautions:

  • Acute herpes zoster infection (RZV and ZVL). Delay until symptoms stabilize.
  • Precaution for RZV. Consider delaying until after delivery.
  • Chronic use of anti-herpes virus medications including acyclovir, valacyclovir, famciclovir (ZVL only)
    • Discontinue 24h prior to ZVL
    • Resume no sooner than 14d after ZVL

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

  • Several vaccines available worldwide, but only 3 available in the United States currently
    • Cominarty® - Pfizer-BioNTech (mRNA)
      • Approved for ages 18 years or older
      • Authorized for ages 6 months to 17 years
    • Spikevax® - Moderna (mRNA)
      • Authorized for ages 6 months or older
    • Jcovden® - Janssen/Johnson & Johnson (ChAdOx1)
      • Authorized for ages 18 years or older
  • mRNA (Pfizer-BioNTech or Moderna) is preferred over Janssen vaccine for both primary and booster vaccination
  • Janssen COVID-19 vaccine should only be used in limited situations due to risk of thrombosis with thrombocytopenia syndrome (TTS)
  • COVID-19 vaccines may be administered with other vaccines during the same visit
  • People who previously received antibody against SARS-CoV-2 as part of COVID-19 treatment, PEP, or PrEP can be vaccinated at any time
  • Children ages 6 months to 11 years old should receive a lower age-appropriate mRNA dose
  • For most up to date and detailed information on authorized or approved COVID-19 vaccines visit: www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19vaccines-us.html

Indications

  • CDC recommends everyone ages 6 months or older should receive COVID-19 vaccine when eligible regardless of a history of SARS-CoV-2 infection

Schedule:

  • COVID-19 Vaccination Schedule for most people by age and vaccine
    • Pfizer-BioNTech
      • Ages 5 years and older
        • Total number of doses: 3-4 depending on age
        • First 2 doses separated by 3-8 weeks
        • 3rd dose given at least 5 months after prior dose
        • For people ages 50 years or older, 4th dose given 4 months after prior dose
      • Ages 6 months through 4 years
        • Total number of doses: 3
          • First 2 doses separated by 3-8 weeks
          • 3rd dose at least 8 weeks after prior dose
          • No additional boosters for those who are moderately or severely immunocompromised
    • Moderna (ages 6 months and older)
      • Total number of doses: 2-4 depending on age
      • First 2 doses separated by 4-8 weeks
      • For people ages 18 years or older, 3rd dose given at least 5 months after prior dose
      • For people ages 50 years or older, 4th dose given 4 months after prior dose
    • Janssen (ages 18 years and older)
      • Total number of doses: 2-3 doses
      • 2nd dose given at least 2 months after prior dose
      • For people ages 50 years or older, 3rd dose with mRNA vaccine 4 months after prior dose
      • People ages 18 year and older who received 2 Janssen doses may get a 3rd dose with mRNA vaccine
  • COVID-19 Vaccination Schedule for Immunocompromised Populations
    • Pfizer-BioNTech for ages 6 months to 4 years old (total 3 doses) as above
    • Pfizer-BioNTech for ages 5-11 years old
      • Total number of doses: 4
        • First 2 doses separated by 3 weeks
        • 3rd dose given 4 weeks after prior dose
        • 4th  dose given 3 months after prior dose
    • Pfizer-BioNTech for ages 12 year or older
      • Total number of doses: 5
        • First 2 doses separated by 3 weeks
        • 3rd dose given 4 weeks after prior dose
        • 4th  dose given 3 months after prior dose
        • 5th  dose given 4 months after prior dose
    • Moderna ages 18 or older
      • Total number of doses: 5
        • First 2 doses separated by 4 weeks
        • 3rd dose given 4 weeks after prior dose
        • 4th dose given 3 months after prior dose
        • 5th dose given 4 months after prior dose
    • Janssen ages 18 or older
      • Total number of doses: 4
      • 2nd dose with mRNA vaccine 4 weeks after prior dose
      • 3rd dose with mRNA vaccine 8 weeks after prior dose
      • 4th dose with mRNA vaccine 4 months after prior dose

Vaccine-specific contraindications:

  • History of a severe allergic reaction (e.g., anaphylaxis) after previous dose or to a component of the COVID-19 vaccine
  • History of known diagnosed allergy to a component of the COVID-19 vaccines
  • For Janssen COVID-19 vaccine:
    • History of TTS
    • History of immune-mediated syndrome characterized by thrombosis and thrombocytopenia (HIT)
    • Guillain-Barré Syndrome within 6 weeks of Janssen administration

Vaccine-specific precautions:

  • History of immediate allergic reaction to any vaccine other than COVID-19 vaccine or any injectable therapy
  • People with history of non-severe, immediate (<4 hours) allergic reaction after a dose of one type of COVID-19 vaccine
  • People with an allergy-related contraindication to one type of COVID-19 vaccine 
  • For mRNA vaccines, history of myocarditis or pericarditis after a dose of mRNA COVID-19 vaccine
  • History of Multisystem Inflammatory Syndrome in either children (MIS-C) or adult (MIS-A)
  • For Janssen COVID-19 vaccine, history of Guillain-Barré Syndrome
  • People with a precaution to any COVID-19 vaccine should be observed for at least 30 minutes after administration, all others should be observed for 15 minutes

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